483
Apitoria Pharma Private LimitedApitoria Pharma Private Limited – FDA 483, May 10, 2024
Record Details
The FDA inspected Apitoria Pharma Private Limited Unit VII in Parawada Mandal, India, from May 6-10, 2024. The inspection revealed significant deficiencies in quality control, specifically regarding the testing and approval of starting materials and drug substances for identity, quality, and purity. These issues led to the release of non-sterile drug substance lots without proper impurity identification and control, indicating a serious lapse in manufacturing oversight.
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ID · ae36b84b-ad18-4b2e-9588-3fe277720017
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